Status:
WITHDRAWN
Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI)
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment.
Eligibility Criteria
Inclusion
- Sign, initialize and date the informed consent form
- Age ≥ 18 years
- For urinary infection diagnosis, the following parameters must be considered in the urine I test:
- Leukocyturia: ≥ 15,000 leukocytes
- Epidermal cells: \< 20,000/mL
- Presence of bacteriuria
- Presence of nitrite (positive results)
- To have a 2 points score (from 12 points) regarding the following symptoms of acute cystitis:
- Dysuria
- Urinary urgency
- Frequent urination
- Pain in the upper area of pubis
- Each symptom must be scored according to the classification below. Total score may range from 0 to 12 points.
- Severity Value Absent 0 Mild 1 Moderate 2 Severe 3
Exclusion
- Research subjects that meet any of the criteria below will not be eligible for the study:
- Asymptomatic urinary infection or infection in any organ
- Documented incidence of UTI in the last year
- Symptoms of pyelonephritis (cystitis symptoms plus fever, lower back pain or chills)
- History of complicated urinary tract infection (congenital abnormalities, urinary tract distortion or obstruction, formation of calculus in the urinary tract)
- Use of catheter in the urinary tract
- Chronic renal or hepatic disease
- Seizure-related diseases
- Neurological deficits that interfere in the urinary flow and tract defense
- Decompensated diabetes mellitus (fasting blood glucose ≥ 150 mg/dL);
- Immunodepression:
- Subjects with the human immunodeficiency virus (HIV)
- Chronic use of corticosteroids in a dose ≥ 5 mg/day of prednisone for over 30 days
- Any diseases related to immune dysfunction
- Severe comorbidities (at the investigator's discretion)
- History of allergy to penicillins, cephalosporines or quinolones
- Subjects on medications such as antibiotics, amiodarone, antacids or sucralphate, tricyclic antidepressants, antipsychotics, cyclosporine, cisapride, didanosine, erythromycin, fembufeno, gliburide (a sulphonilurea), nitrofurantoin, probenecid, procainamide, quinidine, sotalol, teophylline, warfarin
- Treatment due to UTI two weeks before entering study, or on antimicrobial treatment at least 3 times within the last 12 months
- Use of phenazopyridine 7 days before entering the study
- Hospitalization 30 days before study enrollment
- Female research subjects that are pregnant, breastfeeding, or women with childbearing potential that deny to use at least two safe contraceptive methods during study
- Participation in another clinical trial in the last 12 months
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01527019
Start Date
October 1 2012
Last Update
July 27 2015
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